Cleared Traditional

K850529 - SHEER ADHESIVE BANDAGES, STERILE

K850529 is an FDA 510(k) clearance for SHEER ADHESIVE BANDAGES, manufactured by Abco Dealers, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K850529 · Abco Dealers, Inc. · General & Plastic Surgery device
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May 1985
Decision
88d
Days
Class 1
Risk

K850529 is an FDA 510(k) clearance for the SHEER ADHESIVE BANDAGES, STERILE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 10, 1985 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K850529

510(k) Number K850529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1985
Decision Date May 10, 1985
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 183
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K850529.
NITTO SURGICAL PAPER TAPE ST-310
K853647 · Nitto Denko America, Inc. · Sep 1985
EXTRA LARGE ADHESIVE STRIPS
K852408 · American White Cross, Inc. · Jul 1985
TRICOT ADHESIVE BANDAGE
K852462 · American White Cross, Inc. · Jul 1985
VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
K850133 · Consolidated Medical Equipment, Inc. · Feb 1985
LEUKOFIX R
K843873 · Beiersdorf, Inc. · Feb 1985
LEUKOPOR SURGICAL TAPE
K843874 · Beiersdorf, Inc. · Feb 1985
K850529 · SHEER ADHESIVE BANDAGES, STERILE
Download PDF Abco Dealers, Inc.